U.S. patent number 6,889,832 [Application Number 10/057,736] was granted by the patent office on 2005-05-10 for sterile container.
This patent grant is currently assigned to AESCULAP AG & Co. KG. Invention is credited to Lorenz Gabele.
United States Patent |
6,889,832 |
Gabele |
May 10, 2005 |
**Please see images for:
( Certificate of Correction ) ** |
Sterile container
Abstract
In order to design a sterile container for the accommodation and
sterile storage, in particular, of surgical instruments or
material, comprising a receiving area formed by a container base
and container walls, such that it is easy and inexpensive to use it
is suggested that the receiving area comprise a plurality of
separate chambers and that each chamber have its own closure
element.
Inventors: |
Gabele; Lorenz (Sauldorf,
DE) |
Assignee: |
AESCULAP AG & Co. KG
(Tuttlingen, DE)
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Family
ID: |
7916678 |
Appl.
No.: |
10/057,736 |
Filed: |
January 25, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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PCTEP0006124 |
Jun 30, 2000 |
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Foreign Application Priority Data
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Jul 30, 1999 [DE] |
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199 35 986 |
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Current U.S.
Class: |
206/370;
206/213.1; 206/538; 206/571; 422/300 |
Current CPC
Class: |
A61L
2/26 (20130101); A61B 50/30 (20160201); A61L
2202/121 (20130101); A61L 2202/182 (20130101); A61B
2050/0066 (20160201); A61B 2050/0084 (20160201); A61B
2050/311 (20160201); A61B 2050/3015 (20160201); A61B
2050/006 (20160201); A61B 2050/3008 (20160201) |
Current International
Class: |
A61B
19/02 (20060101); A61B 19/00 (20060101); A61L
2/26 (20060101); B65D 083/10 () |
Field of
Search: |
;206/370,366,363,534.1,539,438,439,538,571,213.1 ;422/300,292 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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29 52 733 |
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Jul 1981 |
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DE |
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0 513 614 |
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Nov 1992 |
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EP |
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WO 92/00705 |
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Jan 1992 |
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WO |
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WO 95/09579 |
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Apr 1995 |
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WO |
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Primary Examiner: Mohandesi; Jila M.
Attorney, Agent or Firm: Lipsitz; Barry R. McAllister;
Douglas M.
Parent Case Text
This application is a continuation of international application
number PCT/EP00/06124 fied on Jun. 30, 2000.
The present disclosure relates to the subject matter disclosed in
International application No. PCT/EP00/06124 of Jun. 30, 2000,
which is incorporated herein by reference in its entirety and for
all purposes.
Claims
What is claimed is:
1. Sterile container for the accommodation and sterile storage of
surgical instruments or material, comprising a receiving area
formed by a container base and container walls, the receiving area
comprising a plurality of separate chambers formed by intermediate
walls of the container which divide the receiving area, wherein:
filter openings are provided in said separate chambers; a singel
sterile flter covers the filter openings for several of the
chambers; each chamber has its own separate cover as a closure
element, and a seal is seated between each chamber and its closure
element and completely seals each the chamber.
2. Sterile container as defined in claim 1, wherein the closure
element is arranged so as to be pivotable.
3. Sterile container as defined in claim 1, wherein a closure
element is arranged by means of a sliding guide means.
4. Sterile container as defined in claim 1, wherein the closure
element is at least partially transparent.
5. Sterile container as defined in claim 1, wherein the sterile
container is manufactured at least partially from a transparent
material.
6. Sterile container as defined in claim 1, wherein the seal is
adapted to be acted upon by underpressure.
7. Sterile container as defined in claim 1, wherein the sterile
filter is seated beneath the container base.
8. Sterile container as defined in claim 1, wherein the sterile
container has a holder for the sterile filter.
9. Sterile container as defined in claim 8, wherein the holder is
detachable from the sterile container.
10. Sterile container as defined in claim 8, wherein the holder is
arranged on the sterile container so as to be pivotable.
11. Sterile container as defined in claim 8, wherein the sterile
filter is held in the holder by means of a spring catch.
12. Sterile container as defined in claim 1, wherein a protective
grating is seated between sterile filter and sterile container.
13. Sterile container as defined in claim 12, wherein the
protective grating is permeable to steam.
14. Sterile container as defined in claim 12, wherein the
protective grating is insertable into a holder for the sterile
filter.
15. Sterile container as defined in claim 1, wherein at least one
chamber has a limiting element provided with openings facing the
sterile filter.
16. Sterile container as defined in claim 15, wherein the limiting
element is a respective part of the container base.
17. Sterile container as defined in claim 16, wherein a limiting
element provided with openings for several chambers is formed in
one piece.
18. Sterile container as defined in claim 15, wherein the limiting
element provided with openings of the at least one chamber is
detachable.
Description
BACKGROUND OF THE INVENTION
The invention relates to a sterile container for the accommodation
and sterile storage, in particular, of surgical instruments or
material, comprising a receiving area formed by a container base
and container walls.
Medical instruments and, in particular, surgical instruments for
ward or outpatient requirements have to be stored in a sterile
manner until they are used. For this purpose, soft packs are mainly
used, i.e. the instruments or the material are sealed in
sterilization packs. The packaging of instruments and material and
the sealing of the packs can take considerable time.
Known sterile containers have a relatively high price in comparison
with soft packs.
The object of the invention is to design a generic sterile
container such that it is easy and inexpensive to use.
SUMMARY OF THE INVENTION
This object is accomplished in accordance with the invention, for a
sterile container of the type described at the outset, in that the
receiving area comprises a plurality of separate chambers and that
each chamber has its own closure element.
As a result of providing a plurality--i.e. at least two--separate
chambers, the inventive sterile container may be filled with a
corresponding plurality of instruments and surgical material,
respectively, and sterilized at the same time. As a result, it is
possible to save time in comparison with the packaging of the
instruments and the sealing of the packs. If the articles which are
to be stored in the chambers in a sterile manner are designed such
that they may be sterilized automatically, an entire sterile
container may be sterilized with the instruments accommodated
therein in an automatic device and so a "series sterilization" can
be achieved which may, again, mean a saving on time and costs.
Prior to using the instruments and material, respectively, stored
in a sterile manner, a user opens only the closure element of that
chamber, in which the instrument or material required by him is
contained. The other chambers remain unopened and thus sterile. In
the case of the sterile containers known thus far from the state of
the art, it was a disadvantage that the entire sterile container
had to be opened in order to remove one instrument and, therefore,
all the other instruments became non-sterile insofar as they were
not used immediately.
In the case of operations, for which a defined type and/or number
of instruments are required, for example, in the case of ear, nose
and throat operations, an inventive sterile container which is
designed accordingly may be equipped with the required set of
instruments and these are kept sterile ready for the operation in a
well-organized manner.
In addition, in contrast to bag packs, an inventive sterile
container may be used again following cleaning and
disinfection.
In a particularly favorable embodiment from a constructional point
of view, a chamber has a cover as closure element. This also makes
it possible to carry out the cleaning process and disinfection
process for the sterile container--possibly with instruments
already inserted--more or less automatically.
In a variation of one embodiment it is provided for the closure
element to be arranged so as to be pivotable. As a result, closing
(for the sterile storage of an instrument or of surgical material
in the chamber) or opening (for removal) may be brought about in a
simple manner. It may also be provided for a closure element to be
arranged by means of a sliding guide means.
It is particularly advantageous when the closure element is at
least partially transparent. In this way an operator can easily
recognize what is stored in a chamber. It may also be provided for
the sterile container to be manufactured at least partially from a
transparent material.
In order to obtain a sterile closure in relation to the
surroundings, a seal is favorably seated between the chamber and
the (closed) closure element. It is particularly favorable when the
seal can be acted upon by underpressure. As a result, it is
possible for the closure element or a receiving element of a
chamber for the seal (depending on which element holds the seal) to
be secured by suction to the seal during closing in order to
achieve a particularly good seal in relation to the
surroundings.
It may be provided for the sterile container to have openings in
the container base and/or outer container walls. As a result, the
cleaning/disinfection is facilitated, on the one hand, since
cleaning/disinfection fluids can flow away through the openings. On
the other hand, the possibility is also created, as a result, of
condensation water or steam being able to exit from a closed
chamber.
A sterile filter is then provided for covering the openings; this
sterile filter can, in particular, be a permanent sterile filter.
Such a sterile filter prevents non-sterile air from passing into
the chambers. On the other hand, water or steam, which can
represent a nutrient medium for germs when collected in a chamber,
can, nevertheless, still be discharged from the chamber to the
surroundings via the sterile filter.
It is particularly advantageous when a sterile filter and, in
particular, a single sterile filter is provided for several
chambers. As a result, the time required and also the
constructional resources for the arrangement of the sterile filter
on the sterile container are simplified and, in addition, the
sterile filter may be replaced more quickly than several of such
filters.
Favorably, the sterile filter is seated beneath the container base.
As a result, the container base may be provided with the
corresponding openings for the discharge of steam/water or for the
discharge of fluids during the cleaning and disinfection and such a
cleaning and disinfection process can also be carried out with
instruments inserted, wherein a good discharge of the fluids is
achieved and the instruments need not be held in addition.
Favorably, the inventive sterile container has a holder for a
sterile filter in order to be able to replace sterile filters in
this way or to be able to arrange the sterile filter on the
inventive sterile container after a cleaning and disinfection
process.
In a variation of one embodiment, it may be provided for the holder
to be detachable from the sterile container. As a result, the
cleaning and disinfection process may be made easier in certain
circumstances. It may, however, also be provided for the holder to
be arranged so as to be pivotable in order to pivot it away, in
particular, from the container base in this way during a cleaning
and disinfection process.
It is particularly advantageous when the sterile filter is held in
the holder by means of a spring catch. The sterile filter may then
be replaced in a simple and quick way and, on the other hand, it is
held securely in the holder in order to prevent non-sterile air
from passing into a closed chamber.
Favorably, it is provided for a protective grating to be seated
between sterile filter and container. This protective grating has
the task of avoiding any penetration of the sterile filter by, in
particular, pointed instruments which are stored in the sterile
container, i.e. to protect the sterile filter from leakage. When
the protective grating is permeable to steam, water vapor or water
from the interior of a closed chamber can be discharged.
The protective grating can be favorably inserted into a holder for
the sterile filter. As a result, only one holder for the sterile
filter and the protective grating need be provided.
Favorably, a chamber has a respective limiting element provided
with openings facing the sterile filter. These openings facilitate
the cleaning and disinfection of the chamber and water or water
vapor can also be discharged from the chamber through them when an
instrument or surgical material is stored in it. It is particularly
simple from a constructional point of view when the limiting
element is a respective part of the container base.
Favorably, a limiting element provided with openings for several
chambers is formed in one piece. In this respect, gaps between
adjacent limiting elements, in which germs can collect, are, for
example, avoided.
In a variation of one embodiment, it is favorably provided for the
limiting element provided with openings of one chamber to be
detachable. As a result, the assembly of the inventive sterile
container is, on the one hand, made easier. On the other hand, the
limiting element provided with the openings can be cleaned more
easily when an inventive sterile container is utilized again or
thrown away and a new limiting element inserted. If the openings
are, in particular, very narrow, germs can collect in them and it
may be more advantageous to use a new limiting element instead of a
time-consuming cleaning and disinfection.
The following description of preferred embodiments of the invention
serves to explain the invention in greater detail in conjunction
with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a lateral sectional illustration of a sterile
container;
FIG. 2 shows a plan view of the sterile container of FIG. 1;
FIG. 3 shows a plan view of a second embodiment of a sterile
container and
FIG. 4 shows a further embodiment of an inventive sterile
container;
A sterile container which is designated as a whole as 10 in FIG. 1
comprises a container base 12 and container walls 14. The container
walls themselves comprise outer walls 16, i.e. a front wall 18, a
rear wall 20, a left-hand side wall 22 and a right-hand side wall
24 (FIG. 2).
A receiving area 26 is formed within these outer walls 18, 20, 22,
24, limited by the container base 12. This area is, on the other
hand, subdivided into a plurality of separate chambers 30 by
intermediate walls 28 which extend between the outer walls 16.
In the case of the embodiment shown in FIGS. 1 and 2, the receiving
area 26 is subdivided into eight chambers 30 which have the same
cross section and the same height. For this purpose, a longitudinal
intermediate wall 32 runs centrally between the left-hand side wall
22 and the right-hand side wall 24 and three transverse
intermediate walls 34 extend between the front wall 18 and the rear
wall 20 at equal distances. The intermediate walls 32, 34 are
designed such that the individual chambers 30 are closed so as to
be fluid-tight and gas-tight in relation to one another.
In the case of the additional embodiment shown in FIG. 3, a
single-line chamber subdivision in comparison with the first
embodiment according to FIGS. 1, 2 is shown, with which no
longitudinal intermediate wall 32, as in FIG. 2, is provided. A
fine chamber subdivision is achieved in this embodiment as a result
of the provision of a plurality of parallel transverse intermediate
walls 36.
In the case of the embodiment shown in FIG. 4, a first longitudinal
intermediate wall 38 and a second longitudinal intermediate wall 40
at a distance thereto are arranged parallel to the front wall 18
and the rear wall 20, respectively, so that a chamber subdivision
with three lines is brought about.
Transverse intermediate walls 42 are arranged at a distance from
one another parallel to the left-hand side wall 22 and the
right-hand side wall 24, respectively. This distance need not,
however, be uniform and so individual chambers 30 can have a
different cross section. As a result, an asymmetric chamber
subdivision can be achieved.
It is a matter of course that a plurality of variation
possibilities with respect to the subdivision of the container
result due to the selection of the outer dimensions of the
inventive sterile container, i.e. due to corresponding dimensioning
of the container base 12 and the outer walls 16 as well as
corresponding arrangement and dimensioning of the intermediate
walls 28.
Each chamber 30 has, as shown in FIG. 1, its own closure element
44, which is, in particular, a cover or lid. As a result, the
chamber 30 is closed so as to be germ-tight relative to the outside
(sealed against the penetration of germs) with a closed closure
element 44 such that the sterilized articles, such as a set of
surgical instruments or other surgical material, received by a
cleaned and likewise sterilized chamber remain sterile in the
chamber 30.
An individual closure element 44 for the associated chamber 30 is
arranged, for example, so as to be pivotable on it (not shown in
the drawings) so that the chamber 30 can be opened by pivoting the
associated closure element 44 and the, for example, surgical
material stored in a sterile manner in the chamber 30 can be
accessed in this way. In an alternative embodiment, it may also be
provided for a closure element 44 to be opened and closed by means
of a sliding guide means. Such a sliding guide means may be used,
in particular, in a single-line embodiment of the sterile
container, as shown in FIG. 3.
A seal 46 is advantageously arranged between a closure element 44
in its closed state and the chamber 30. For example, the
corresponding container walls (side walls 22, 24, transverse
intermediate walls 34, longitudinal intermediate walls 32) have,
for this purpose, corresponding projections 48 which serve as
support for the associated closure element 44 (in the case of a
pivotable arrangement). The seal 46 is then seated on these
projections 48 facing the closure element 44 so that, with a closed
closure element 44, this causes a sealing of the chamber 30 in
relation to the surroundings. The seal 46 may be a seal acted upon
by underpressure which is securely seated, in particular, on the
projections 48 (for example, by means of an adhesive connection)
and when the closure element 44 is closed is secured on this by way
of suction in order to bring about an increased leak-tightness.
The container base has an opening element 50 which is provided with
openings 52 which preferably extend parallel to the container walls
14 and at right angles to the container base 12 through it. The
opening element 50 is dimensioned such that each chamber 30 of the
sterile container 10 has such openings 52 in its base.
It may, in particular, be provided for the opening element 50 to
not be formed in one piece with the rest of the sterile container
10 but rather to be removable.
A sterile filter 54 is seated between the outside and the openings
52 and this prevents non-sterile air from passing into the chambers
30 via the openings 52 and thus making articles stored in the
chambers 30 non-sterile. However, the sterile filter 54
facilitates, on the other hand, a passage of water vapor from the
chambers 30 to the surroundings. The sterile filter 54 is, in
particular, a permanent sterile filter, such as, for example, a
filter consisting of PTFE (polytetrafluoroethylene) or a ceramic
filter. The sterile filter 54 has somewhat larger dimensions than
the opening element 50 in order to prevent non-sterile air from
being able to pass into the sterile container 10 (FIG. 1).
The inventive sterile container 10 has a holder 56 for the sterile
filter 54. This is designed, for example, such that it has a spring
catch, by means of which the sterile filter 54 may be inserted into
it and snaps shut when a predetermined position is reached (in
which all the openings 52 can be covered) in order to make a quick
insertion or change of the sterile filter 54 possible, on the one
hand, and, on the other hand, to bring about a secure covering of
the openings 52.
The holder 56 is advantageously arranged on the sterile container
10 so as to be pivotable so that it can be pivoted away, in
particular, during a cleaning process of the sterile container
10.
In addition, it may be provided for a protective grating 58 to be
seated in the holder 56 between the sterile filter 54 and the
openings 52. This protective grating 58, which consists, for
example, of metal, is of such a close-meshed design that it
protects the sterile filter 54 from any penetration by a pointed
instrument possibly stored in a chamber 30. In this respect, it may
be provided, in particular, for the width of the mesh and a width
of the webs of a mesh-forming netting to be selected such that as
few residues as possible from the washing and disinfection process
remain on the protective grating 58. In order to make an exchange
of steam with the surroundings possible, the protective grating 58
must be permeable to steam.
The closure elements 44 are preferably designed to be at least
partially transparent so that an operator can recognize sets of
surgical instruments or material stored in a chamber 30 even when a
closure element 44 is closed. It may also be provided for one or
several container walls 14 to be of a transparent design in order
to facilitate the view from outside of the articles stored in the
chambers 30.
The inventive sterile container may be used as follows:
When closure elements 44 are opened or removed and when a sterile
filter 54 is not inserted or a holder 56 is pivoted away,
instruments to be sterilized are placed in the respective chambers
30 or are already in the chambers, into which they have been
returned after use. The (open) sterile container 10 with the
"filled" chamber 30 is then prepared, i.e. a cleaning and
disinfection process is carried out. The cleaning and disinfection
fluid may flow away via the openings 52. Subsequently, the closure
elements 44 are closed and the sterile filter 54 inserted in order
to then sterilize the entire container.
Prior to using the respective instrument or surgical material, an
operator opens via the associated closure element 44 only that
particular chamber 30 which contains the desired instrument. The
operator can recognize this via the transparent closure element 44.
The chambers not opened remain sterile, i.e. the articles stored in
them do not become non-sterile due to the opening of another
chamber 30.
Cleaning and sterilization methods other than the automatic method
described above may also, of course, be used in order to store, in
particular, water-sensitive surgical materials, such as bandaging
materials, in the chambers 30 in a sterile manner.
* * * * *